Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00505934
Status:
COMPLETED
Last Update Posted:
2015-07-15
First Post:
2007-07-20
Brief Title:
Open-label Study of Levetiracetam Intravenous Infusion in Children 1 Month-4 Years Old With Epilepsy
Sponsor:
UCB Pharma SA
Organization:
UCB Pharma
Study Overview
Official Title:
Open-label Single-arm Multi-center Pharmacokinetic Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children 1 Month- 4 Years Old With Epilepsy
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Keppra injection is approved in the US as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy The objective of the current study is to assess the safety tolerability and pharmacokinetics of this formulation in children aged 1 month to 4 years
Detailed Description:
The primary objective of this study was to evaluate the safety and tolerability of levetiracetam intravenous 15-minute infusion administered every 12 hours either as adjunctive treatment or monotherapy in children 1 month to 4 years old with epilepsy except status epilepticus either after switching from the equivalent levetiracetam oral dose administration or as a new antiepileptic treatment
The evaluation period was to be considered as one complete set of 4 pharmacokinetic PK samples for a maximum of 4 days
For children already taking levetiracetam oral solution prior to entering the study the levetiracetam intravenous LEV IV dose will be equivalent mg-for-mg to their oral dose always in twice daily regimen within the following dose range calculated on the basis of their age and weight
Children 1 month to 6 months 14 mgkgday ie 7 mgkg twice daily to 42 mgkgday ie 21 mgkgday twice daily
Children 6 months to 4 years20 mgkgday ie 10 mgkg twice daily to 60 mgkgday ie 30 mgkgday twice daily
The first intravenous IV infusion was to be administered 12 hours after the last oral dose of levetiracetam
For children not taking levetiracetam oral solution prior to entering the study the intravenous IV dose will correspond to their age and weight as follows
Children 1 month to 6 months 14 mgkgday ie 7 mgkg twice daily
Children 6 months to 4 years 20 mgkgday ie 10 mgkg twice daily
However when necessary for the safety of the subject or when the investigator deemed it appropriate the levetiracetam intravenous LEV IV dose could be modified after one day
Subjects were hospitalized for the duration of the levetiracetam intravenous LEV IV treatment
The evaluation period was to be considered as one complete set of 4 pharmacokinetic PK samples for a maximum of 4 days
For children already taking levetiracetam oral solution prior to entering the study the levetiracetam intravenous LEV IV dose will be equivalent mg-for-mg to their oral dose always in twice daily regimen within the following dose range calculated on the basis of their age and weight
Children 1 month to 6 months 14 mgkgday ie 7 mgkg twice daily to 42 mgkgday ie 21 mgkgday twice daily
Children 6 months to 4 years20 mgkgday ie 10 mgkg twice daily to 60 mgkgday ie 30 mgkgday twice daily
The first intravenous IV infusion was to be administered 12 hours after the last oral dose of levetiracetam
For children not taking levetiracetam oral solution prior to entering the study the intravenous IV dose will correspond to their age and weight as follows
Children 1 month to 6 months 14 mgkgday ie 7 mgkg twice daily
Children 6 months to 4 years 20 mgkgday ie 10 mgkg twice daily
However when necessary for the safety of the subject or when the investigator deemed it appropriate the levetiracetam intravenous LEV IV dose could be modified after one day
Subjects were hospitalized for the duration of the levetiracetam intravenous LEV IV treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007-003517-13 | EUDRACT_NUMBER | None | None |